Stockwinners Market Radar for May 20, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:48 EDT Resolute Forest announces ratification of four-year collective agreement - Resolute Forest Products announced ratification of a four-year collective agreement by Unifor union members at seven of the company's pulp and paper mills in Canada, following an agreement-in-principle reached on May 15. The collective agreements cover approximately 700 hourly employees represented by Unifor at Resolute's Dolbeau; Gatineau; Kenogami; Saint-Felicien and currently indefinitely idled Amos and Baie-Comeau pulp and paper facilities in Quebec; and the Thunder Bay operation in Ontario. The seven mills account for about 50% of the company's total pulp and paper production capacity.

17:01 EDT National Research Corporation announces new 2.5M share repurchase program - On May 19, the company's Board of Directors approved a new stock repurchase authorization of up to 2.5M shares of its common stock. The new authorization follows the company's recent repurchase of all shares remaining under the Board's previous repurchase authorization.

16:46 EDT TOP Ships receives noncompliance notification from Nasdaq - TOP Ships announced that it has received written notification from Nasdaq, indicating that because the closing bid price of the company's common stock for the last 30 consecutive business days was below $1.00 per share, the company no longer meets the minimum bid price requirement for the Nasdaq, set forth in Nasdaq Listing Rule 5450. Pursuant to the Nasdaq Listing Rules, the applicable grace period to regain compliance is 180 days, or until November 14. The company intends to monitor the closing bid price of its common stock between now and November 14 and is considering its options, including a reverse stock split, in order to regain compliance with the Nasdaq minimum bid price requirement. The company can cure this deficiency if the closing bid price of its common stock is $1.00 per share or higher for at least ten consecutive business days during the grace period. The company intends to cure the deficiency within the prescribed grace period. During this time, the company's common stock will continue to be listed and trade on the Nasdaq. The company's business operations are not affected by the receipt of the notification.

16:41 EDT Elon Musk: We will never surrender/settle an unjust case against us - In a tweet, Elon Musk said, "We will never seek victory in a just case against us, even if we will probably win. We will never surrender/settle an unjust case against us, even if we will probably lose."

16:17 EDT Armstrong Flooring trading halted, news pending

16:11 EDT Glory Star New Media receives noncompliance notice from Nasdaq - Glory Star New Media announced that it received a written notice from the Listing Qualifications Department of Nasdaq indicating that the company is not in compliance with the minimum bid price requirement of $1.00 per share under the Nasdaq Listing Rules. Based on the closing bid price of the company's listed securities for the last 30 consecutive business days from April 6 to May 18, the company no longer meets the minimum bid price requirement set forth in Listing Rule 5550(a)(2). The notice is only a notification of deficiency, not of imminent delisting, and has no current effect on the listing or trading of the company's securities on the Nasdaq Capital Market. The notice states that under Listing Rule 5810(c)(3)(A), the company is provided with a compliance period of 180 calendar days, or until November 15, to regain compliance with the listing rules. To regain compliance with the Listing Rules, the company's listed securities must be at least $1.00 for a minimum of ten consecutive business days. In the event the company does not regain compliance by November 15, the company may be eligible for additional time to regain compliance or may face delisting.

16:09 EDT Vera Therapeutics announces new data from Phase 2a JANUS trial - Vera Therapeutics announced new clinical data for its lead product candidate, atacicept, from the Phase 2a JANUS trial in patients with IgA nephropathy and first-time results from a post-hoc analysis of the Phase 2 APRIL-SLE study in patients with systemic lupus erythematosus. These data were included in two oral presentations at the European Renal Association - European Dialysis Transplant Association Congress being held May 19-22, in Paris, France, in person and virtually. In the Phase 2a randomized, placebo-controlled JANUS trial in 16 IgAN patients, patients were evaluated for serum anti-Gd-IgA1 at baseline, weeks 4, 12, 24, 48, and 72. Results showed a decrease in serum anti-Gd-IgA1 levels was observed in both atacicept 25 mg and 75 mg groups over time. At 24 weeks, the mean percent change from baseline was a 24 percent decrease for atacicept 25 mg and a 29 percent decrease for atacicept 75 mg. At 72 weeks, a 28 percent decrease for atacicept 25 mg and 39 percent decrease for atacicept 75 mg was observed. APRIL-SLE was a double-blind, placebo-controlled, Phase 2 study that randomized patients with moderate-to-severe SLE to atacicept 75 mg, atacicept 150 mg, or placebo twice-weekly for 4 weeks, then weekly for 48 weeks. In total, 111 patients in the placebo group, 112 patients in the atacicept 75 mg group, and 62 patients in the atacicept 150 mg group completed 52 weeks of treatment. Results showed the estimated glomerular filtration rate time course was stable for the atacicept groups compared to a 4.4 percent decline in the placebo group from baseline at week 52. The urine protein creatine ratio from baseline at week 52 declined in the atacicept groups and increased in the placebo group.

16:02 EDT Latch announces reset of cost structure - Latch announced the completion of a workforce reduction. Additionally, the company is announcing the reorganization of the sales and marketing departments under the leadership of Lee Odess. Prior to this role, Odess was the GM of New Market Development at Latch. Odess is a proven leader in the industry with nearly 20 years of experience driving sales growth, product innovation, and geographic expansion for leading companies in the smart access and security space. Latch believes that, along with the recently announced reorganization of its product organization and revised sales compensation structure focused on recurring software revenue, these changes will position the company for long-term growth while also accelerating its path towards self-sustaining free cash flow and profitability. Latch expects this reduction in force will better align staffing and expense levels with current sales volumes and the current macroeconomic environment, with continued construction delays and supply chain shortages. The reduction impacts approximately 130 people, or approximately 28% of Latch's full-time employees. Once fully implemented, Latch expects to achieve approximately $40M annual run rate cost savings across research and development, sales and marketing and general and administrative expenses. The reduction is expected to result in approximately $4M-$6M of total cash restructuring and related charges primarily related to severance and benefits costs, substantially all of which is expected to be incurred in the second quarter of 2022. Latch's guidance provided in its first quarter earnings release does not reflect the recently completed workforce reduction. Latch intends to provide further information about this reorganization and updated guidance in connection with the release of Latch's second quarter earnings. As of March 31, Latch had cash plus marketable securities of $335M, and continues to believe it is fully capitalized to fund its growth plan to free cash flow breakeven.

15:23 EDT Hyundai Motor announces pact with State of Georgia to build EV facilities - Hyundai Motor announced it has entered into an agreement with the State of Georgia to build its first dedicated full electric vehicle and battery manufacturing facilities in the U.S. "The Group's U.S. investment decision will support its goal of becoming a leader in electric mobility in the U.S. market. It also highlights the Group's commitment to sustainability through electrification and to supporting the economies where it operates... The new EV plant and battery manufacturing facilities represent an investment of approximately $5.54B. The new facility will break ground in early 2023 and is expected to begin commercial production in the first half of 2025 with an annual capacity of 300,000 units. The battery manufacturing facility will be established through a strategic partnership, which the details will be disclosed at a later stage. The Group plans to produce wide range of full electric vehicles for U.S. customers at the new Georgia EV plant. Details of production models will be shared at later dates. The local EV production will increase U.S. consumer accessibility to the Group's innovative EVs. Through the battery manufacturing facility, the Group also aims to establish a stable supply chain and build a healthy EV ecosystem in the U.S.," the company stated.

14:43 EDT FDA approves Regeneron's Dupixent to treat eosinophilic esophagitis - The U.S. Food and Drug Administration approved Dupixent to treat eosinophilic esophagitis, or EoE, in adults and pediatric patients 12 years and older weighing at least 40 kilograms. "Today's action marks the first FDA approval of a treatment for EoE," the FDA stated. Dupixent received priority review and breakthrough therapy designations for this indication. Dupixent was originally approved in 2017. It is approved for the treatment of moderate-to-severe atopic dermatitis in adult and pediatric patients aged 6 and older whose disease is not adequately controlled by topical prescription therapies or when those therapies are not advisable. Dupixent is also approved as an add-on maintenance treatment of adults and pediatric patients aged 6 and older with certain types of moderate-to-severe asthma, as well as an add-on maintenance treatment in adults with inadequately controlled chronic rhinosinusitis with nasal polyposis. The FDA granted the approval of Dupixent to Regeneron Pharmaceuticals.

13:02 EDT Baker Hughes reports U.S. rig count up 14 to 728 rigs - Baker Hughes reports that the U.S. rig count is up 14 from last week to 728 with oil rigs up 13 to 576, gas rigs up 1 to 150 and miscellaneous rigs unchanged at 2. The U.S. Rig Count is up 273 rigs from last year's count of 455 with oil rigs up 220, gas rigs up 51 and miscellaneous rigs up 2. The U.S. Offshore Rig Count is unchanged at 18, up 4 year-over-year. The Canada Rig Count is unchanged from last week at 88, with oil rigs up 3 to 40, gas rigs down 3 to 48. The Canada Rig Count is up 30 rigs from last year's count of 58, with oil rigs up 15, gas rigs up 15.

12:53 EDT JE Cleantech Holdings Ltd trading resumes

12:09 EDT Aurinia: Use of Lupkynis 'safe,' well-tolerated' for up to 3 years - Aurinia Pharmaceuticals presented for the first time the results of the AURORA 2 continuation study evaluating the long-term safety and tolerability of LUPKYNIS for the treatment of adults with active lupus nephritis, a serious complication in patients with systemic lupus erythematosus. The results were presented during an oral session at the 59th European Renal Association Congress, held in Paris and virtually May 19-22, 2022. The AURORA 2 study assessed long-term safety and tolerability of voclosporin compared to placebo in patients with LN receiving treatment for an additional 24 months following completion of one year on treatment in the AURORA 1 study. The primary endpoint was safety and included assessments of adverse events, deaths, and hematological assessments. Secondary endpoints include renal response, renal flare, renal outcomes, and changes in urine protein to creatinine ratio and estimated glomerular filtration rate. Voclosporin was well tolerated during the study period with a similar safety profile to control and no unexpected safety signals. Specific findings included: Overall rates of serious adverse events were similar in both the controland voclosporin arms and there was no increase in infectious events. Generally adverse events were low and decreased over time on treatment. Significant and meaningful reductions in proteinuria achieved in AURORA 1 were maintained. In AURORA 2, there was a significant difference in eGFR slope in favor of voclosporin compared to control arm. There was a small, expected, and early decrease in mean eGFR in the first four weeks of treatment in AURORA 1, after which eGFR remained stable through the end of AURORA 2. There were four deaths in the active control group during AURORA 2, while none in the voclosporin-treated group.

12:00 EDT Kohl's falls -12.2% - Kohl's is down -12.2%, or -$5.50 to $39.54.

12:00 EDT Deckers Brands rises 11.7% - Deckers Brands is up 11.7%, or $26.43 to $253.22.

12:00 EDT Leju rises 37.6% - Leju is up 37.6%, or $1.19 to $4.35.

10:47 EDT Cboe actively investigating issue with MATCHNow - Cboe stated in a system status message posted on its website: "MATCHNow has identified an issue with trade reporting that affects Willing-to-Trade, or 'WTT,' aka 'Conditionals Opt-In Feature' activated, orders. MATCHNow has disabled the WTT port defaults that allow day certain large size day orders, aka 'Liquidity Providing orders,' to become eligible to trade with Conditionals until such time as the issue is resolved. Further updates will follow when available. All other Cboe MATCHNow systems are operating normally." Reference Link

10:27 EDT Chinook announces two oral presentations on atrasentan clinical program - Chinook Therapeutics announced two oral presentations on the atrasentan clinical program and Evotec collaboration at the 59th ERA Congress 2022 being held virtually and live in Paris, France. "We are very encouraged by the data we presented today on atrasentan from the IgAN patient cohort of the phase 2 AFFINITY basket trial, demonstrating highly consistent and clinically meaningful proteinuria reductions at weeks six, 12 and 24 of treatment in patients with IgAN already on a maximally tolerated and stable dose of a RAS inhibitor. This level of proteinuria reduction is likely to translate into significant clinical benefit for patients with IgAN who currently have limited treatment options and high unmet need," said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics. "The magnitude and deepening of response observed over time is distinct from the previous treatment experience with atrasentan in DKD where proteinuria reductions plateaued after a few weeks of treatment. We believe this dataset provides strong readthrough to the topline proteinuria data from the phase 3 ALIGN trial expected in 2023."

10:16 EDT Deere sees 'strong' industry demand in 2023

10:12 EDT Deere: U.S. road-building demand 'strong' - Comments taken from Q2 earnings conference call.

10:09 EDT HLVX Stock trading resumes

10:04 EDT HLVX Stock trading halted, volatility trading pause

10:00 EDT Deere falls -8.2% - Deere is down -8.2%, or -$29.97 to $334.65.

10:00 EDT Eve Holding rises 15.4% - Eve Holding is up 15.4%, or $1.29 to $9.64.

10:00 EDT Deckers Brands rises 19.8% - Deckers Brands is up 19.8%, or $44.85 to $271.64.

09:47 EDT Borr Drilling falls -8.6% - Borr Drilling is down -8.6%, or -48c to $5.07.

09:47 EDT Foot Locker rises 9.5% - Foot Locker is up 9.5%, or $2.86 to $33.16.

09:47 EDT Eve Holding rises 21.6% - Eve Holding is up 21.6%, or $1.80 to $10.15.

09:41 EDT MDXH Stock trading resumes

09:39 EDT Burlington Stores drops 12% after peer Ross cuts outlook

09:38 EDT Covetrus jumps 15% after confirming receipt of $21 per share buyout proposal - Shares of Covetrus are up $2.73, or 15%, to $20.75 after the company disclosed in a regulatory filing earlier that on May 19 the company acknowledged that the company had received a non-binding proposal from funds affiliated with Clayton, Dubilier & Rice, or "CD&R," and TPG Global, collectively, the "sponsors," to acquire all of the company's outstanding shares of common stock not already owned by the Sponsors or their affiliates for cash consideration of $21.00 per share. The board of directors of the company previously formed a transaction committee of directors comprising non-management directors that are independent of CD&R. Prior to the making of the proposal, the company granted CD&R a limited waiver of the standstill restrictions contained in the Investment Agreement, dated April 30, 2020, by and among the company and CD&R VFC Holdings, L.P., an affiliate of CD&R, in order to permit the submission of the proposal, as well as to permit CD&R to engage with the company, through the transaction committee or as otherwise directed, to pursue, develop and, if later approved by the board upon the recommendation of the transaction committee, enter into the transaction contemplated by the proposal.

09:31 EDT Foot Locker sees FY22 comparable sales down 8%-10% - Says high percentage of multi-unit baskets have multiple brands. Says 80% of highest frequency shoppers buy multiple brands. Says Instagram following well above peers. Says store traffic was up more than 25% in Q1. Sees FY22 capital expenditures $275M. Sees FY22 comparable sales down 8%-10%. Says expects Q2 and Q4 to be toughest comparisons for the year. Says quarter-to-date May has been in line with expectations. Says expects to open 100 new stores and close 190 stores in FY22. Says expects supply chain costs to be a drag on margins. Says expects FY22 expense rate to be flat to up 20 basis points. Comments and guidance taken from Q1 earnings conference call.

09:23 EDT Lear to acquire I.G. Bauerhin for EUR 140M on a cash-and debt-free basis - Lear announced it has entered into a definitive agreement to acquire I.G. Bauerhin, a privately held supplier of automotive seat heating, ventilation, active cooling, steering wheel heating, seat sensors, and electronic control modules. Lear will acquire IGB for EUR 140M, on a cash- and debt-free basis. The transaction, subject to regulatory approvals and other customary closing conditions, is expected to close in the next six to nine months.

09:21 EDT Trinity Biotech announces CE Mark for 10-minute COVID-19 antigen test - Trinity Biotech has achieved a CE Mark for its 10-minute Covid-19 antigen test. This CE mark allows for use by healthcare professionals and trained users. The Company intends to launch the test throughout the European Union as well as other countries that recognise the CE Mark designation. In addition to its ease-of-use and impressive speed to result, in extensive clinical trails the test has demonstrated excellent 99% sensitivity and 99% specificity which are accuracy levels superior to many of the tests currently on the market. The test uses an anterior nasal swab sample rather than the more invasive nasopharangeal swab, providing a more comfortable patient experience. The test also has several features that benefit the user including a convenient pre-filled extraction buffer and a run time of 10 minutes which is faster than many competitor products. This speed to result and pre-filled buffer allows a higher throughput of patients for healthcare professionals and trained users performing the test, while also providing a more comfortable patient experience without compromising on diagnostic performance.

09:17 EDT Wells Fargo Advisors to pay $7M to settle SEC charges - The Securities and Exchange Commission announced charges against Wells Fargo Advisors for failing to file at least 34 Suspicious Activity Reports in a timely manner between April 2017 and October 2021. Wells Fargo Advisors, the St. Louis-based broker-dealer, has agreed to pay $7M to settle the charges. According to the SEC's order, due to Wells Fargo Advisors' deficient implementation and failure to test a new version of its internal anti-money laundering transaction monitoring and alert system adopted in January 2019, the system failed to reconcile the different country codes used to monitor foreign wire transfers. As a result, Wells Fargo Advisors did not timely file at least 25 SARs related to suspicious transactions in its customers' brokerage accounts involving wire transfers to or from foreign countries that it determined to be at a high or moderate risk for money laundering, terrorist financing, or other illegal money movements. The order also found that, beginning in April 2017, Wells Fargo Advisors failed to timely file at least nine additional SARs due to a failure to appropriately process wire transfer data into its AML transaction monitoring system in certain other situations. Wells Fargo Advisors, without admitting or denying the SEC's findings, agreed to a censure and a cease and desist order.

09:08 EDT VivoPower, Tembo announce DSA agreement with Toyota Australia - VivoPower International (VVPR) announces that it has executed a Design Services Agreement, DSA, with Toyota Motor (TM) Corporation Australia Limited for its wholly owned subsidiary, Tembo e-LV to be commercially engaged in relation to the next stage of design of electrification solutions for the Toyota LandCruiser 70 for off-road applications in Australia. The DSA reflects the commercial next step in Tembo's collaboration programme with TMCA, which was initially announced as a binding letter of intent in June 2021. VivoPower has established a Tembo subsidiary in Australia and will commit dedicated Tembo resources to this important programme. VivoPower's Executive Chairman and CEO, Kevin Chin said, "We are honoured to have entered into this commercial agreement with TMCA and are fully committed to working closely with the TMCA team to deliver an electrified LandCruiser 70, which is fit for purpose and safe for corporate fleets, especially for off road use cases such as mining. In this regard, we have now dedicated a team within Tembo that is solely focused on this important TMCA project. We will also be sub-contracting our partner in Australia, GB Auto, given their dedicated mining sector experience."

09:07 EDT Altamira Therapeutics announces top-line data from Bentrio nasal spray trial - Altamira Therapeutics announced top-line data from its clinical trial with Bentrio nasal spray in house dust mite, or HDM, allergic rhinitis. The HDM challenge trial demonstrated a statistically significant reduction of nasal symptoms vs. untreated controls as well as good tolerability and safety. Bentrio is a drug-free nasal spray intended for personal protection against airborne viruses and allergens with a triple mode of action. At a single Canadian study site, the trial enrolled a total of 37 patients with a history of perennial allergic rhinitis caused by HDM exposure. Study participants were randomized under an open label, three-period crossover design to receive either Bentrio in a single or double dose, or no treatment, prior to controlled allergen exposure in an environmental exposure chamber for three hours. The primary endpoint was the change in the Total Nasal Symptom Score from baseline. The ANCOVA model showed that Bentrio treatment reduced the increase in mean TNSS during the 3-hour exposure by 1.1 points vs. no treatment. Under Bentrio treatment, the mean TNSS was 4.1 points vs. 5.2 points under no treatment. The changes in TNSS started to separate at the 40-minute time point and, on average, reached 1.5 to 2 points from the mid-point to the end of exposure. The protective effect was observed both with a single or double puff per nostril with no meaningful difference between the two treatment approaches. Regarding safety, there were only few adverse events, mostly mild, and more than 85% of study participants rated the tolerability of Bentrio as "good" or "very good."

09:05 EDT Radius Health appoints Jennifer Jarrett, Susan Vissers Lisa to board - Radius Health announced that it has added two new independent members to the Board of Directors. Effective immediately, Jennifer Jarrett and Susan Vissers Lisa have joined the Board as Class I and Class III directors, respectively. In addition, Radius' Board also announced several corporate governance changes to further enhance shareholder input. Of the expanded Board's 10 directors, nine are independent. Jarrett, 51, is currently COO and serves on the Board of Arcus Biosciences, a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer. Susan Vissers Lisa, 53, recently served as Senior Vice President, Investor Relations of CVS Health Corporation through April 2022. In line with corporate governance best practices, the Company's Board has proposed reducing the vote required to amend the charter and bylaws from a supermajority to a majority of the shares outstanding, subject to approval by Radius' shareholders at this year's upcoming Annual Meeting. In addition, the Board has adopted a "proxy access" provision to allow long-term shareholders to nominate directors in the Company's proxy statement.

09:03 EDT MiMedx announces Glass Lewis recommends shareholder vote 'FOR ALL' proposals - MiMedx Group announced that leading proxy advisory firm Glass Lewis & Co has recommended that shareholders vote "FOR ALL" of the Company's proposals including "FOR" both of MIMEDX's director nominees James Bierman and Phyllis Gardner, M.D. - on the WHITE proxy card at its 2022 Annual Meeting of Shareholders scheduled for Tuesday, June 7, 2022. Commenting on Glass Lewis' recommendation, MIMEDX issued the following statement: "We are pleased that Glass Lewis has recommended shareholders vote "FOR" our stated proposals, particularly the election of MIMEDX's highly qualified director nominees - James L. Bierman and Phyllis Gardner, M.D. Glass Lewis also recommended, in its report, that shareholders vote "FOR" the Company's say-on-pay proposal, recognizing "the Company's active engagement efforts and positive program changes" in response to last year's say-on-pay vote. Glass Lewis concluded that "in light of these considerations, as well as the adequate alignment between pay and performance, we believe that shareholders may reasonably support this proposal." Glass Lewis goes on to acknowledge that MIMEDX's executive compensation, including that of our Chief Executive Officer, is in line with the median compensation for a group of its peers."

09:03 EDT Altamira announces topline results from trial of Bentrio nasal spray - Altamira Therapeutics announced positive top-line data from its clinical trial with Bentrio nasal spray in house dust mite allergic rhinitis. The HDM challenge trial demonstrated a statistically significant reduction of nasal symptoms vs. untreated controls as well as good tolerability and safety. Bentrio is a drug-free nasal spray intended for personal protection against airborne viruses and allergens with a triple mode of action. At a single Canadian study site, the trial enrolled a total of 37 patients with a history of perennial allergic rhinitis caused by HDM exposure. Study participants were randomized under an open label, three-period crossover design to receive either Bentrio in a single or double dose, or no treatment, prior to controlled allergen exposure in an environmental exposure chamber for three hours. The primary endpoint was the change in the Total Nasal Symptom Score from baseline. The ANCOVA model showed that Bentrio treatment reduced the increase in mean TNSS during the 3-hour exposure by 1.1 points vs. no treatment. Under Bentrio treatment, the mean TNSS was 4.1 points vs. 5.2 points under no treatment. The changes in TNSS started to separate at the 40-minute time point and, on average, reached 1.5 to 2 points from the mid-point to the end of exposure. The protective effect was observed both with a single or double puff per nostril with no meaningful difference between the two treatment approaches. Regarding safety, there were only few adverse events, mostly mild, and more than 85% of study participants rated the tolerability of Bentrio as "good" or "very good."

09:02 EDT XpresSpa announces 10M share increase in stock repurchase - XpresSpa Group announced that its Board of Directors has authorized a 10M share increase to its existing stock repurchase program and to extend it through September 15, 2023. The original stock repurchase program, announced in August 2021, was for 15M shares, and there were approximately 3.2M shares remaining under that original authorization as of the date of such increase, bringing the current authorization to approximately 13.2M shares. Since initiating the stock repurchase plan on August 31, 2021, the Company has repurchased approximately 11.8M shares through March 31, 2022 for total consideration of approximately $18.9M. Bruce Bernstein, Chairman of the Board of XpresSpa Group, stated, "Our balance sheet strength positions us well to execute on the expanded stock repurchase program while we invest in the continued growth of the Company. The expansion of this authorization also further validates our belief that our stock is substantially undervalued." The share repurchase authorization will be used at management's discretion and will expire on September 15, 2023, unless further extended by the Board of Directors. The repurchase program may also be suspended, modified, or discontinued at any time.

08:50 EDT Novartis reports positive CHMP opinion for expanded use of Cosentyx in children - Novartis announced the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has adopted a positive opinion for Cosentyx, used alone or in combination with methotrexate, in the juvenile idiopathic arthritis, or JIA, categories of enthesitis-related arthritis and juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. "The positive CHMP opinion reinforces that children and adults living with immunologic rheumatic and dermatological diseases, and the physicians who treat them, may feel confident in the management of these diseases with Cosentyx. We're committed to bringing innovative treatments to young people living with rheumatic diseases across the world. With recent approvals in the US, Japan and Brazil, we are one step closer in our ambition to expand Cosentyx to 10 indications in areas of high unmet need," said Todd Fox, Global Head of Medical Affairs Immunology at Novartis.

08:47 EDT Rayonier increases quarterly cash dividend 5.6% to 28.5c per share - Rayonier announced that its board of directors has approved a 5.6% increase in its quarterly cash dividend to 28.5c per common share from 27c per common share. The dividend is payable on June 30, to shareholders of record on June 16. The company also announced that the company's board of directors, in its capacity as the board of directors of the general partner of Rayonier, L.P., has declared a second quarter cash distribution of 28.5c per operating partnership unit, which also reflects a 5.6% increase. The cash distribution is payable on June 30 to holders of record on June 16.

08:46 EDT Deere cuts FY22 operating cash flow view to $5.6B-$6B from $6.2B-$6.6B - Cuts FY22 effective tax rate view to 22%-24% from 25%-27%.

08:43 EDT Boeing successfully launches Starliner spacecraft to orbit in test flight - NASA said Thursday that Boeing's CST-100 Starliner is in orbit, heading for the International Space Station following launch of the next-generation spacecraft on a United Launch Alliance Atlas V rocket on a mission designed to test the end-to-end capabilities of the crew-capable system as part of NASA's Commercial Crew Program. Starliner lifted off on NASA's Boeing Orbital Flight Test-2 at 6:54 p.m. EDT from Space Launch Complex-41 at Cape Canaveral Space Force Station in Florida. Following an orbital insertion burn 31 minutes later, Starliner was on its way for a rendezvous and docking with the space station. "I am so proud of the NASA, Boeing and United Launch Alliance teams who have worked so hard to see Starliner on its way to the International Space Station," said NASA Administrator Bill Nelson. "Through adversity, our teams have continued to innovate for the benefit of our nation and all of humanity. I look forward to a successful end-to-end test of the Starliner spacecraft, which will help enable missions with astronauts aboard." Reference Link

08:39 EDT Xcel Energy partners with IFS to drive field workforce scheduling transformation - Xcel Energy is partnering with IFS, the global cloud enterprise software company, to undertake a gas and electric distribution end-to-end scheduling transformation. As a part of the transformation, Xcel Energy will utilize mobile workforce management and planning and scheduling optimization software from IFS, with an integration to SAP via an add-on component.

08:33 EDT ContraFect announce board approved grant of inducement stock option awards - ContraFect announced that on May 16, 2022, the Compensation Committee of the Company's Board of Directors approved the grant of inducement stock option awards to purchase an aggregate of 15,000 shares of its common stock to two new non-executive employees. The awards were granted under ContraFect's 2021 Employment Inducement Omnibus Incentive Plan, which was adopted on September 14, 2021 and provides for the granting of equity awards to new employees of ContraFect. The stock options awarded have a ten-year term and an exercise price of $3.20 per share, which is equal to the closing price of ContraFect's common stock on The Nasdaq Capital Market on May 16, 2022. Each option will vest over a four-year period, with 25% of the shares vesting after 12 months and the remaining shares vesting quarterly over the following 36-months, subject to each employee's continued service with the Company on such vesting dates.

08:33 EDT Volcon signs 100th dealer to sell EVs in North America - Volcon has officially signed 100 dealers to sell its electric vehicles in North America. With an increasing focus on electric alternatives to transportation and recreational vehicle options, Volcon was quick to sign up a solid list of experienced dealerships in North America. Volcon dealers across the country are prepared and excited to sell Volcon products to their existing and growing customer bases. North America dealers will begin receiving Volcon Grunts for their sales floors as of the second week of May 2022 with every dealer in the network having placed orders as part of their onboarding process.

08:32 EDT Frontdoor CEO Rexford Tibbens to step down, chairman William Cobb to succeed - Frontdoor announced that William Cobb, chairman of the Frontdoor board of directors, will succeed Rexford Tibbens, president, CEO and a member of Frontdoor's board of directors, effective June 1. Tibbens has decided to step down from these roles and will remain with Frontdoor through June 30 in an advisory capacity to ensure a leadership transition. Cobb has served as chairman of the Frontdoor board of directors since October 2018.

08:25 EDT Nio up 7% in pre-market after company announced Singapore exchange listing - Shares of Nio are up about 7% at $17.80 in pre-market trading. Overnight, the company announced that it has "successfully listed, by way of introduction, its Class A ordinary shares on the Main Board of the Singapore Exchange Securities Trading Limited". CEO William Bin Li stated: "Today marks a new milestone for NIO. The listing on the SGX-ST has further strengthened NIO's footing in the global capital markets. Furthermore, by leveraging Singapore's advantageous position as an international innovation and technology center, NIO plans to establish a research and development center for artificial intelligence and autonomous driving in Singapore and to collaborate with local science and research institutions to further broaden and enhance our global R&D capabilities."

08:16 EDT AbbVie submits NDA to FDA for ABBV-951 - AbbVie announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration for ABBV-951 for the treatment of motor fluctuations in patients with advanced Parkinson's disease. The submission is based on results from a Phase 3, head-to-head, randomized and controlled clinical trial demonstrating statistically significant improvement in "On" time without troublesome dyskinesia compared to oral immediate-release carbidopa/levodopa.

08:13 EDT DoorDash discloses $400M share repurchase program - In a regulatory filing, the board of directors of DoorDash authorized the repurchase of up to $400M shares of the company's Class A common stock. The goal of the program is to offset a portion of the dilution associated with restricted stock units issued to employees as part of the company's overall compensation program.

08:05 EDT Greenpro incubated company Angkasa-X to build Satellite Ground Station Centre - Greenpro Capital announced that its incubated company, Angkasa-X and Universiti Sains Malaysia to build Satellites Ground Station and Space Technology Centre in Penang, Malaysia, The construction of the Angkasa-X Earth Groundstation and the Space Technology Centre is in preparation for the launching and deployment of Angkasa-X's constellation of A-SEANSAT & A-SEANLINK LEO satellites. With this ground segment infrastructure in place, Angkasa-X is geared to work together with the E&E industry in the development of Spacetech Ecosystem in realising the ASEAN Space Economy.

08:04 EDT CCL Industries announces TSX acceptance of normal course issuer bid - CCL Industries announced that the Toronto Stock Exchange has accepted a notice filed by the Company to commence a normal course issuer bid. Under the Bid, the Company is authorized to acquire up to 14,500,000 of its Class B non-voting shares, being approximately 9.9% of the public float of the Class B non-voting shares as of May 16, 2022. No Bid is proposed to be made for the Company's Class A voting shares. All purchases will be made through the facilities of and in accordance with the rules of the TSX and all shares purchased will be cancelled. Except where reliance is placed on the TSX's block purchase exemption, the maximum number of shares that could be purchased under the Bid on any trading day will be limited to 70,789 Class B non-voting shares. The average daily trading volume for the six-month period ended April 30, 2022, was 283,157 Class B non-voting shares. The Bid will commence on May 25, 2022, and end no later than May 24, 2023. CCL's management believe that such purchases are an appropriate and desirable use of available funds. Pursuant to a previous notice of intention to conduct a normal course issuer bid, under which Company sought and received approval from the TSX to purchase up to 8,000,000 Class B non-voting shares for the period of May 25, 2021 to May 24, 2022, the Company has purchased, as of May 16, 2022, 1,805,888 Class B non-voting shares on the open market at an average purchase price of $57.78 per share. As of May 16, 2022, the issued and outstanding number of Class B non-voting shares was 166,709,007 and the public float of the Class B non-voting shares was 146,835,777. Purchases were made through the facilities of the TSX and all shares purchased were cancelled.

08:03 EDT BiomX publishes NGS-related data in Bioinformatics journal - BiomX announced the publication of a scientific paper titled "Exodus: Sequencing-based Pipeline for Quantification of Pooled Variants" in the journal, Bioinformatics. The research was conducted by scientists at BiomX and is available online. The paper specifically relates to overcoming the limitations of Next Generation Sequencing, or NGS, in identifying and quantifying genetically-related microorganisms after they are pooled together in either natural or designed samples. BiomX researchers have developed a reference-based Python algorithm, Exodus, for quantification of genomes, including those that are highly similar, when they are sequenced together in a single mix. Applying the Exodus algorithm, researchers were able to generate both empirical and in-silico next generation sequencing data of mixed genomes with median error rates between 0% and 0.21% as a function of the complexity of the mix. Importantly, no false negatives were recorded, which BiomX believes demonstrates that Exodus' likelihood of missing an existing genome is very low, even if the genome's relative abundance is low and similar genomes are present in the same mix.

08:02 EDT Genius Group acquires E-Squared Education Enterprises - Genius Group has acquired E-Squared Education Enterprises, a South Africa-based, entrepreneur-focused primary and secondary school and vocational college. Genius Group has attracted over 2.7M students in 200 countries, ranging from primary and secondary school students to startup founders and experienced entrepreneurs. The acquisition of E-Squared Education Enterprises will further enhance E-Squared's offering and bring campuses and a range of trusted programs to their portfolio. E-Squared is situated in Nelson Mandela Bay, South Africa. Roger James Hamilton, Founder & CEO of Genius Group says: "E-Squared Education Enterprises is a valuable addition to our entrepreneurial education offering. Africa has seen a dramatic increase in entrepreneurs over the last decade, and educating future generations to be resourceful and entrepreneurial has never been of more important." Lili Niemann will remain CEO of E-Squared Education Enterprises.

07:38 EDT Beachbody Company COO buys $500K in common stock - In a regulatory filing, Beachbody disclosed that its COO Kathy Vrabeck bought 468K shares of common stock on May 17th in a total transaction size of $500K.

07:36 EDT LiqTech interim CEO buys $1.0M in common stock - In a regulatory filing, LiqTech disclosed that its interim CEO Alexander Buehler bought 2M shares of common stock on May 17th in a total transaction size of $1.0M.

07:33 EDT BridgeBio announces data from Phase 2 trial of PTR-01 - BridgeBio Pharma announced data from the Phase 2 trial of PTR-01, an intravenously-administered recombinant collagen 7 protein replacement therapy, in patients with recessive dystrophic epidermolysis bullosa, RDEB. The data are being shared in a poster at the Society for Investigative Dermatology, SID, Annual Meeting 2022. The Phase 2, open-label study was designed to examine the effect of PTR-01 on wound healing as well as other endpoints, and to evaluate the long-term safety and tolerability of the drug candidate. The data shared at the 2022 SID Annual Meeting demonstrated that PTR-01 was well tolerated when given once per week for 4 weeks and then every other week for 14 weeks. In addition, treatment with PTR-01 led to rapid, consistent, and durable wound healing as observed in reduction of wound surface area and clinician-reported assessments. Specifically, over 80% of target wounds demonstrated a 50% or greater reduction in wound surface area at the end of treatment compared to baseline. Notably, this response was observed in a breadth of wound types: recurrent and chronic; and a range of wound sizes: large and small, as determined by at least 50% reduction in wound surface area compared to baseline. Clinician assessment of the same target lesions scored on a 7-pt scale compared to baseline demonstrated similar levels of efficacy and wound improvement. By day 15 after initiating treatment, 15 of 26 wounds met the response criteria of greater than or equal to2-point increase on the wound-specific scale, and at day 120, 18/26 wounds met the response criteria. Patient-reported outcomes measuring pain, essential function, mood, activities of daily living and disease impact also showed marked mean and median reductions comparing end of study to baseline. Notably, all patients that completed the study reported a decrease in pain over the course of treatment with PTR-01. There was a 36% mean reduction in total pain from end of study compared to baseline. Finally, systemic administration of PTR-01 resulted in rapid deposition of rC7 at the DEJ during the loading phase and remained present up to 3 months after treatment.

07:29 EDT Match Group withdraws request for temporary restraining order against Google - Match Group (MTCH) announced it has withdrawn its request for a temporary restraining order against Google (GOOG, GOOGL), after Google made various concessions that Match Group demanded to benefit consumers. Those include guaranteeing that Match Group apps will still be allowed to offer users choice in payment systems, lessening the undue burden on developers by its previously stated policy, and eliminating Google's complete control over user data. In exchange for withdrawing the temporary restraining order, Google has conceded the following: Match Group apps will not be rejected or removed from the Google Play Store because they offer alternatives to Google Play Billing. Google will approve Match Group app updates that offer alternatives to Google Play Billing, continuing to provide users with the choice and optionality they've grown accustomed to. Google will work - in good faith - to fix the deficiencies of Google Play Billing, outlined HERE. When Google addresses these problems, Match Group apps that currently do not offer Google Play Billing will - in good faith - test Google's system on their platforms, alongside current payment systems. As part of this arrangement, Match Group plans to put up to $40M into an escrow account, instead of paying Google directly for billing transactions that occur on Android outside of Google Play Billing. Match Group maintains that the fees Google is demanding for payments outside of Google Play Billing are illegal under federal and state law. No other app or product in Google Play currently pays Google for transactions that occur outside of Google Play Billing. But, because of Google's complete monopoly control over the Android app distribution ecosystem, Match Group has agreed to hold funds in escrow and maintain the status quo of Match Group apps in the Google Play Store, until the Court hears and adjudicates the claims filed against Google on May 9 for violating federal and California antitrust laws. Both Match Group and Google can terminate this agreement, but Match Group retains the option to reinstate its request for a TRO if that should happen. The date for the trial is currently set for April 2023. Match Group believes that Google's behavior will be found to be anticompetitive, in violation of federal and state antitrust laws, and the funds in the escrow account will be returned to Match Group for reinvestment in the business and benefit of consumers.

07:18 EDT ACM Research appoints Armanino LLP as auditor for 2022 - ACM Research announced that Armanino LLP has been appointed as ACM's independent registered public accounting firm to audit ACM's consolidated financial statements for the fiscal year ending December 31, 2022. "ACM's engagement of Armanino as independent auditor for 2022 completes ACM's previously announced process to identify and appoint an independent public accounting firm subject to inspection by the Public Company Accounting Oversight Board, in order to enable ACM to comply with provisions of the U.S. Holding Foreign Companies Accountable Act of 2020, or HFCAA. ACM expects that, upon issuance of consolidated financial statements for the fiscal year ended December 31, 2022 that have been audited by Armanino, ACM would no longer appear on the SEC's 'Conclusive list of issuers identified under the HFCAA,' and would no longer be subject to the related delisting guidelines of the HFCAA. ACM will request that its stockholders ratify the appointment of Armanino as independent auditor for 2022 at ACM's Annual Meeting of Stockholders scheduled to be held on June 30, 2022," the company stated.

07:06 EDT Kohl's shareholder Macellum Advisors issues statement regarding board - Macellum Advisors, a long-term holder of nearly 5% of the outstanding common shares of Kohl's, issued the following statement regarding the company and its board of directors attributable to its managing partner, Jonathan Duskin: "This quarter's extremely disappointing results do not change the fact that Kohl's is a uniquely positioned retailer with tremendous long-term opportunities to increase sales, expand margins and produce superior earnings. Based on our extensive analysis of Kohl's and the retail sector, we can say with great conviction that yesterday's results are simply a consequence of a weak Board and management configuration leading to a flawed strategic plan and an inability to execute. Under the right oversight and leadership that has sufficient expertise and a viable strategy, we firmly believe Kohl's will consistently deliver superior operating and financial results. It was alarming to learn yesterday that the current Board appears to have withheld material information from shareholders about the state of Kohl's in the lead-up to this year's pivotal annual meeting. We believe all of the Company's shareholders should feel betrayed and outraged by the fact that the quarter's massive earnings miss, reduced guidance and the imminent departures of two senior executives, who presumably supported the development of Kohl's' three-year strategy released in March 2022, were not disclosed prior to last week's annual meeting. If any of the current directors were aware of this material information prior to the annual meeting, their involvement in any decision to withhold the news prior to a monumental shareholder vote suggests to us a clear breach of fiduciary duty. If any of the current directors were kept in the dark and not aware of this information prior to the annual meeting, we urge this faction of the Board to retain independent counsel and begin its own investigation to understand how select directors and shareholders were so grossly misled and what recourse they have. Either way, Kohl's should immediately appoint three of our nominees - including a shareholder representative from Macellum - to the Board to replace three long-serving incumbents. Keep in mind that Institutional Shareholder Services, Inc., a leading independent proxy advisory firm, recommended earlier this month that shareholders vote to elect multiple Macellum nominees, including former Macy's, Inc. Chief Merchandising Officer Jeff Kantor and former L Brands, Inc. Chief Financial Officer Pamela Edwards. At this point, we believe the current Board has forfeited its right to continue to oversee Kohl's and review offers versus the Company's internal plan - and it should immediately commit to accepting the highest financed acquisition offer received at the conclusion of the sale process. We are actively exploring claims against the Board and will take legal action, if necessary, to protect our interests as a major long-term shareholder and the interests of all our fellow shareholders."

07:04 EDT Caribou raises $115M in Series C funding - Caribou announced it has closed $115 million in an oversubscribed Series C funding round, which brings the company's valuation to $1.1 billion. The round was led by Goldman Sachs Asset Management, with participation from new investors, including Innovius Capital and Harmonic, as well as existing investors, including Accomplice, CMFG Ventures, Curql Fund, Firebolt Ventures, Gaingels, Moderne Ventures, Motley Fool Ventures and others. Auto lending is the fastest growing consumer credit market in the U.S., with total auto debt having doubled to roughly $1.5 trillion in little more than 10 years. With the cost of car ownership soaring, Caribou is providing consumers with much-needed financial relief, saving its customers on average more than $100 a month on their auto loan through refinancing. The company is expanding its services across the auto financial landscape, recently launching its digital car insurance marketplace. Founded in 2016, Caribou has rapidly grown its core auto refinancing offering by connecting car owners with lenders from credit unions, community banks and other trusted financial institutions. Caribou now also provides a quick and easy way to shop and compare car insurance from trusted national carriers in minutes with its new car insurance marketplace. By combining technology with expert lending and insurance teams, Caribou is prioritizing transparency and trust in the car ownership experience. Since closing its first auto loan for customers a little over four years ago, Caribou has refinanced more than $1.5 billion in loans, saving its customers over $100 million in total interest over the lifetime of their loans. The company has simultaneously scaled its business operations across Washington D.C. and Denver, as well as remotely, building a 500-person workforce, up from roughly 40 employees two years ago. The Series C funding round will help Caribou to continue its strong growth trajectory by investing in its platform, innovative new products and continuing to expand the team.

07:02 EDT Meritor to acquire Siemens' Commercial Vehicles business for EUR 190M in cash - Meritor (MTOR) announced that it has entered into an agreement with Siemens (SIEGY) to acquire its Commercial Vehicles business for approximately EUR 190M in cash, adjusted for changes in working capital at closing. The transaction is expected to close by calendar year-end, subject to regulatory approvals and customary closing conditions. With approximately 200 employees across Germany, China and the United States, the Siemens Commercial Vehicles business develops, designs and produces high-performance electric drive systems. In accordance with the terms of the previously announced Merger Agreement under which Cummins (CMI) agreed to acquire Meritor, Cummins consented to and is supportive of Meritor entering into the agreement and completing its acquisition of the Siemens Commercial Vehicles business.

06:54 EDT Deere sees FY22 net income $7B-$7.4B - "Looking ahead, we believe demand for farm equipment will continue benefiting from positive fundamentals in spite of availability concerns and inflationary pressures affecting our customers' input costs," May said. "The company's smart industrial strategy and recently announced Leap Ambitions are focused on helping customers manage higher costs and increasingly scarce inputs, while improving their yields, through the use of our integrated technologies."

06:26 EDT WhatsApp announces new products for business messaging - Mark Zuckerberg announced yesterday that WhatsApp is opening up a new, cloud-based version of the WhatsApp Business Platform, hosted by Meta, to any business across the world. With this new API, WhatsApp is offering free, secure cloud hosting services so businesses and developers can easily access our service within minutes, build directly on top of WhatsApp to customize their experience and increase their response time for their customers. For smaller businesses using the WhatsApp Business app, the company is building tools so it's easier to handle an influx of chats as they grow their customer base. WhatsApp also announced a way for businesses to keep the conversation going with Recurring Notifications. This new capability makes it easy to re-engage people right in the messaging thread and deliver tailored messaging for customers, whether to hear about special promotions, new product drops or tips and tricks. We also highlighted our click-to-message ads to help customers immediately start conversations with businesses.

06:07 EDT Cloopen receives noncompliance notification from NYSE - Cloopen announced that, on May 18, it received a letter from the New York Stock Exchange, or NYSE, notifying the company that it is not in compliance with the NYSE's continued listing standards as a result of the company's failure to timely file its annual report on Form 20-F for the fiscal year ended December 31, 2021. The company expects to file the 2021 Annual Report, upon the outcome of the pending internal investigation as disclosed in the company's current report on Form 6-K initially furnished to the U.S. Securities and Exchange Commission, or SEC, on May 3 and the completion of the audit of the company's consolidated financial statements required to be included in the 2021 annual report. The anticipated filing date of the 2021 annual report is currently unknown, and the company will file the 2021 annual report as soon as practicable.

06:02 EDT New York City REIT urges shareholders to vote on the Gold proxy card - New York City REIT sent a letter urging shareholders to act quickly to vote the Gold card "FOR" the reelection of Elizabeth Tuppeny at the company's May 31 Annual Meeting, which will protect the value their investment and help NYC continue its strong performance. In the letter, NYC reiterates the exceptional value created by the current Board of Directors with Elizabeth Tuppeny serving as Lead Independent Director, including: An attractive 40c per share annual dividend consistently delivered to shareholders; A total return of 70% from January 1, 2021 through April 13, 2022, outperforming the S&P 500 by 47% and the company's direct competitor set by 48%; and Continued leasing momentum across NYC's portfolio, including two recent non-binding LOIs for new leases with tenants, totaling over 13,500 square feet and $650,000 of annual base rent. The letter also underscores Tuppeny's extensive commercial real estate industry experience, with is superior to Comrit Investments 1, LP's hand-picked nominee, Sharon Stern, whose minimal New York City real estate and public board experience will disrupt the significant progress NYC is making on behalf of shareholders. NYC strongly encourages all shareholders to vote on the GOLD proxy card "FOR" the reelection of Elizabeth Tuppeny and protect their investment. Further, NYC advises shareholders discard the "white" proxy card that they may receive from Comrit.

05:42 EDT Excelerate Energy, Gasgrid Finland Oy subsidiary sign ten-year FSRU agreement - Excelerate Energy and a subsidiary of Gasgrid Finland Oy signed a ten-year contract in Helsinki to charter a floating storage and regasification vessel, or FSRU, that will provide flexible, reliable, and secure liquefied natural gas, or LNG, to Finland, Estonia, and the Baltic Sea Region. Under the time charter party agreement, Excelerate will deploy its FSRU Exemplar to provide regasification services in Southern Finland. The Exemplar has storage capacity of 150,900 m3 of LNG and can provide more than 5 billion cubic meters per year, or bcm/y, of regasification capacity. Per the cooperation agreement signed on May 4 by Gasgrid Finland and Estonia's gas transmission operator Elering AS, the FSRU may be located in an Estonian port this winter if the port structures are not yet completed in Finland. The Governments of Finland and Estonia published a memorandum of understanding on April 29 agreeing to jointly lease an FSRU.

05:19 EDT LumiraDx receives Emergency Use Listing for LumiraDx SARS-CoV-2 Ag Test - LumiraDx announced that its rapid COVID-19 antigen assay, LumiraDx SARS-CoV-2 Ag Test has successfully received the Emergency Use Listing, or EUL, by the World Health Organization, or WHO, in their latest response effort to combat COVID-19.

05:13 EDT Radius Health, Menarini announce data from EMERALD trial published - Menarini and Radius Health announced that data from the pivotal phase 3 EMERALD clinical trial evaluating elacestrant as a monotherapy vs. standard of care for the treatment of ER+/HER2- advanced or metastatic breast cancer were published in the Journal of Clinical Oncology. Elacestrant is the first oral selective estrogen receptor degrader, or SERD, demonstrating a significant improvement in PFS vs. SOC with manageable safety in a phase 3 trial for patients with ER-positive/HER2-negative advanced breast cancer. Patients had disease progression during or within 1 month following 1 or 2 lines of endocrine therapy and a cyclin-dependent kinase, or CDK, 4/6 inhibitor. Patients could also have received 1 line of chemotherapy. 43% received 2 prior endocrine therapies for advanced breast cancer, 22% received chemotherapy for advanced breast cancer and 48% had detectable ESR1 mutation. Patients were randomized 1:1 to elacestrant or SOC choice of fulvestrant or AI; the protocol recommended that patients previously treated with fulvestrant receive AI and patients previously treated with AI receive fulvestrant. Among the 477 patients enrolled in the trial, 239 received elacestrant. Of the 165 patients who received fulvestrant all were pretreated with AI during the treatment for metastatic disease except six who received fulvestrant. Of the 73 who received AI all were pretreated with fulvestrant except four. Primary endpoints were PFS by blinded independent central review (IRC) in all patients and patients with detectable ESR1 mutations. Elacestrant significantly reduced the risk of disease progression or death by 30% in all patients and by 45% in patients with ESR1 mutation. PFS was prolonged in all patients. PFS was prolonged in patients with ESR1 mutation. PFS rate at 12 months with elacestrant was 22.3% vs. 9.4% with SOC in the overall population, and 26.8% vs. 8.2% in the ESR1 mutation population. The most common treatment emergent adverse events, or AEs, in patients receiving elacestrant were mild or moderate gastrointestinal events. Nausea was the most common AE. Any severity: 35% of patients receiving elacestrant and 16% fulvestrant, 25% receiving AI. Severe: 2.5% of patients receiving elacestrant and 0.9% receiving SOC. Treatment-related grade 3/4 AEs occurred in 7.2% of patients receiving elacestrant and 3.1% receiving SOC. Treatment was discontinued due to a treatment-related AEs in 3.4% receiving elacestrant and 0.9% receiving SOC. A subgroup analysis of patients with no prior chemotherapy in EMERALD will be presented at ASCO 2022. Menarini plans to pursue combination studies and study the potential of elacestrant to be effective in addressing the highest unmet needs for ER+/HER2-patients.